What if your product has the ability to achieve multiple indications in multiple therapeutic areas? How do you decide the best way to proceed in order to invest in the top opportunities with the highest return on investment? What are the leading differentiating claims that a sales representative will need in order to sell your product successfully versus the competition? How should you approach your product development journey with a successful end in mind? If only you had a crystal ball…

These are all vital questions that can be clearly answered using a robust Target Product Profile (TPP) process that drives important regulatory, clinical, preclinical, marketing, health economic and reimbursement strategies for your product. TPP is an essential multi-disciplinary tool, a living document, a link from discovery to market entry that helps align the strategy development across the various functions. In 2007, FDA released draft guidance regarding the Target Product Profile as a “strategic development process tool.” The FDA Guidance document is primarily aimed at drug development, however, device and diagnostic companies can adapt principles from its content that are relevant to Medical Device & Diagnostics programs.

The TPP process for Medical Device & Diagnostics is a disciplined planning approach that involves cross-functional discussions comparing your product to standard of care or a top competitor’s product. In order to best position your product in the marketplace, the TPP process involves a thorough evaluation of each product (yours and the competition) by comparing:

desired indications

safety and efficacy claims

pricing and reimbursement

product valuation for each indication

differentiating product features

exclusivity measures

Ultimately, by following the same disciplined TPP approach for all products and indications in your portfolio, comparisons for portfolio decisions are much easier to make, particularly considering the resource and financial constraints that every organization faces.

During this presentation, you will discover how the TPP process can provide your company with a clear advantage in early clinical development, leading to the greatest possibility of approval and successful product launch.

Ms. Hunsicker comes to Premier Research with extensive leadership experience in global clinical research and product development. Most recently she was Senior Director, Global Clinical Operations at LifeCell Corporation, Bridgewater, NJ, where she was responsible for executive oversight of all global clinical research and development activities, the execution of complex strategic clinical plans and compliance with regulatory requirements worldwide. Perhaps even more important, she demonstrated a consummate ability to foster cross-functional relationships, communication and cooperation. Prior to LifeCell, Ms. Hunsicker was Vice President, Global Clinical Operations at Allergan Medical, Vice President, MD&D Project Management at Novella, and Director of Clinical Programs at J&J’s Closure Medical. She received an MBA from Moravian College, Bethlehem, PA and Master of Science in Nursing degree as a Certified Registered Nurse Practitioner from Villanova University, Villanova, PA.

“Medical device clinical research requires a special understanding of all types of unique medical devices and diagnostics, with a host of different patient populations. That’s what makes it so interesting and so exciting!” – Kimberly Hunsicker

OUR XTALKS PARTNER FOR THIS EVENT

Premier Research is a leading global contract research organization serving highly innovative biotech, pharmaceutical and medical technology companies.The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia, neurology, cardiovascular, dermatology, oncology and medical devices.

Premier Research has 24 offices across the globe. It employs over 1,000 clinical professionals. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.